Unitat de Recerca. CAP Sant Pere
Reus, Tarragona, 43202, Spain
NCT Number: NCT02151669
Epidemiologic studies suggest that some nutrients can be affected lung function. Moreover, no previous studies have prospectively evaluated the effect of the Mediterranean dietary pattern in lung function in smokers. Phase II of the RESET study , a clinical trial to evaluate the efficacy of a motivational smoking intervention based on information obtained by spirometry (FIS project PI11/01962).
Looking for future studies?
Notify Me35 year–70 year
All sexes
Interventional
Not applicable
Reus, Tarragona, 43202, Spain
Design: Multicenter randomized controlled trial in primary care. Sample: We will recruit 80 smokers from 35 to 70 years without history of lung disease. Subjects will be randomly assigned to control or intervention group (1:1).
Study variables: We measure socio-demographic, clinical, anthropometry and spirometry data. Food consumption will be evaluated by a semi-quantitative food frequency questionnaire (FFQ), energy expenditure in physical activity by the Minnesota Leisure Time Activity questionnaire and adherence to Mediterranean Diet by a 14-item questionnaire.
Intervention: Nutritional intervention conducted by a dietitian who designs a nutrition program to enhance the traditional Mediterranean diet pattern using new technology as an educational tool in primary care: DIET blog. Participants will be referred to a single annual visit and one group session per year for two years.
Analysis: All analyses will be based on intention-to-treat. The results will be considered clinically relevant when it detects a difference in lung function (decreased FEV1) >10-12 ml/year. A p-value of <0.05 will defined statistical significance.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Nutritional intervention conducted by a dietitian who designs a nutrition program to enhance the traditional Mediterranean diet pattern using new technology as an educational tool in primary care: DIET blog. Participants will be referred to a single annual visit and one group session per year for two years.
Time frame: 2 years
Assess the relationship between lung function and adherence to a Mediterranean Diet and its components
Time frame: 2 years
Assess the relationship between lung function and anthropometric parameters such as waist circumference and BMI.
Time frame: 2 years
To evaluate the effectiveness of using an nutritional educational tool 2.0 to increase adherence to a Mediterranean diet: blog.
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Other
EFFECT OF A MEDITERRANEAN DIET INTERVENTION IN PULMONARY FUNCTION IN SMOKERS: A MULTICENTER RANDOMIZED CLINICAL TRIAL IN PRIMARY CARE CENTERS
Acronym: DIET
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07421349
Children, Ear Diseases
Istanbul, Sakarya, Turkey (Türkiye)
View Trial DetailsNCT06876961
Arm Cycle Ergometer, Colectomy
Al Muharraq, Bahrain
View Trial DetailsNCT07528222
Pathologic Processes, Pathological Conditions, Signs and Symptoms
Taipei, Taiwan
View Trial DetailsNCT06629454
Behavior, Health Behavior
Cherry Hill, New Jersey, United States
View Trial Details